Implementation of the preparatory stage of the CR of medicines. Devising and writing the protocol of the investigation, investigator’s brochure, the text of the informed consent and other materials for patients, CRF and other necessary documents.
Consulting on the issues of statistic methodology and patients’sample size calculation. Preparation of full documentation for obtaining the permission to conduct the CI from the ethics committee at the federal agency monitoring the quality of medicines.
Preparation of the complete package and technical support in obtaining the permission for the CR drugs in the Ministry of Health and Social Development of the Russian Federation.
Organization and realization of the CR. Choosing the research centres, organization of the launching meetings, initiation and closing of the clinical centers, formation of contracts, organization of importation, distribution, storage, return and destruction of research materials.
Creation of databases on paper, electronic, magnetic or optical media, checking, evaluation of reliability and data encryption. Central or local randomization of patients.
Monitoring research centers. Preparation of an integrated report on the CR and assistance in publishing the results.
Pre-registration examination, preparation and maintenance of documents necessary for the Russian federal registration of medicines submitted to the Department of State quality control of medicines.
At sponsor’s will our company is ready to offer any other services within its capability.